• Lead the development of clear, accurate, and compliant regulatory documents for global health authorities (FDA, EMA, PMDA), serving as the author for complex submissions • Author and oversee critical regulatory documents including: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, regulatory submission dossiers (e.g., NDA, IND, MAA) and summary documents, such as summaries of safety and efficacy. • Serve as the regulatory writing lead for high-priority programs, managing end-to-end document development from strategy through submission, including coordination of cross-functional input and review cycles • Analyze complex scientific and medical information, including clinical trial data, and translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences. • Work closely with cross-functional teams (e.g., clinical, biostatistics, regulatory affairs, pharmacology, safety) to gather data and ensure comprehensive and accurate documentation. • Drive continuous improvement in regulatory writing processes, templates, and standards, implementing best practices and innovative approaches to enhance efficiency and quality • Analyze and synthesize complex scientific, clinical, and nonclinical data from multiple sources to create compelling, scientifically rigorous regulatory narratives that address anticipated health authority questions